A Study of Prolonged Electrocardiographic Monitoring in Patients With Heart Failure in Sinus Rhythm or Atrial Fibrillation

NCT02707744 | Completed Results

• 1 other identifier: 15IC2955
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

It is an observational study in patients with heart failure investigating the incidence of arrhythmias using a wearable device which can monitor heart rhythm for up to 14 days. In addition to gathering routine clinical information, research assessments include a symptoms questionnaire and a corridor walk test. Patients will be followed for clinical events (interventions for arrhythmias, hospitalisation, death) for 1 year.

Conditions

Heart Failure; Atrial Fibrillation

Keywords

Heart Failure; Atrial Fibrillation; Ambulatory ECG monitor

Outcome Measures

Primary Outcomes (1)

• Number of Participants With an Identified Dysrhythmia on Baseline ECG Recording

  A dysrhythmia will be defined as either 1. Arrhythmia for which there is a Class I or IIa recommendation for treatment with medication or devices in ESC guidelines. 2. One or more of the following even if it does not otherwise meet guideline-indication for treatment: * Sinus bradycardia ≤30bpm for ≥one minute * High-degree atrioventricular (AV) block (3rd degree or Mobitz Type I or II) * Pauses lasting ≥3 seconds (either sinus or AV block) * Frequent ventricular ectopy defined as \>1,000 ectopic beats per day. * Ventricular tachycardia with rate ≥100 bpm for ≥5 beats.

  on enrollment

Secondary Outcomes (6)

• Combined Endpoint Made up of Cardiovascular Mortality or Hospitalisation for the Management of Heart Failure/Arrhythmia or Implantation of Any Permanent Device Capable of Pacing the Heart.

  From date of enrollment until the date of first hospitalization for management of heart failure/arrhythmia or date of implantation of any permanent device capable of pacing the heart or cardiovascular death, whichever came first, assessed up to 1 years

• All Cause Mortality

  1 year

• Cardiovascular Mortality

  1 year

• Total Number of Hospitalisations for the Management of Heart Failure or Arrhythmia

  1 year

• Total Number of Patients Implanted With Any Permanent Device Capable of Pacing the Heart

  1 year

Study Arms (2)

sinus rhythm

patients with heart failure and sinus rhythm

Other: no intervention

atrial fibrillation

patients with heart failure and atrial fibrillation

Other: no intervention

Interventions

no intervention OTHER

atrial fibrillation; sinus rhythm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with heart failure

You may qualify if:

• Heart Failure
• Treated with Loop Diuretics for at least six weeks
• Willing and legally able to sign informed consent
• At least 18 years of age
• New York Heart Association (NYHA) class II - IV

You may not qualify if:

• Myocardial infarction in the previous six weeks,
• Implanted pacemaker, including cardiac resynchronisation device, or defibrillator
• Already participating in an interventional randomized controlled trial assessing effects on morbidity and mortality (this study does not preclude participation in future clinical trials).

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (3)

Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

Royal Brompton & Harefield NHS Foundation Trust

London, UB9 6JH, United Kingdom

Location

Northwick Park Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Yura Mareev
• Organization: Imperial College

mareev84@gmail.com

+79166364410

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: March 14, 2016
• Study Start: February 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: July 27, 2023
• Results First Posted: July 27, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)